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MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-03-18
Completion Date
2039-10-26
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Calderasib
MK-1084 oral tablet
MK-3475A
Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
Placebo
Placebo oral tablet
Locations (120)
Instituto Alexander Fleming ( Site 0310)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Parque ( Site 0311)
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306)
CABA, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)
CABA, Argentina
Northern Beaches Hospital ( Site 3009)
Frenchs Forest, New South Wales, Australia
Princess Alexandra Hospital ( Site 3012)
Woolloongabba, Queensland, Australia
Peninsula University Hospital ( Site 3011)
Frankston, Victoria, Australia
PRONUTRIR ( Site 0425)
Fortaleza, Ceará, Brazil
AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0414)
Vitória, Espírito Santo, Brazil
Hospital Madre Teresa ( Site 0420)
Belo Horizonte, Minas Gerais, Brazil
Real Hospital Portugues ( Site 0418)
Recife, Pernambuco, Brazil
Faculdade de Medicina do ABC ( Site 0415)
Santo André, São Paulo, Brazil
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0424)
Taubaté, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0416)
São Paulo, Brazil
Moncton Hospital ( Site 0200)
Moncton, New Brunswick, Canada
CIUSSS- saguenay-Lac-Saint-Jean ( Site 0216)
Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0219)
Montreal, Quebec, Canada
Clínica MEDS La Dehesa ( Site 0509)
Lo Barnechea, Region M. de Santiago, Chile
Fundación Arturo López Pérez ( Site 0501)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 0503)
Santiago, Region M. de Santiago, Chile
Bradford Hill ( Site 0508)
Santiago, Region M. de Santiago, Chile
Peking University People's Hospital ( Site 2100)
Beijing, Beijing Municipality, China
Beijing Cancer hospital ( Site 2106)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 2105)
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital ( Site 2138)
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Fujian Medical University ( Site 2123)
Fuzhou, Fujian, China
Fujian Cancer Hospital ( Site 2122)
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center ( Site 2134)
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital ( Site 2115)
Nanning, Guangxi, China
Fourth Hospital Of Hebei Medical University ( Site 2107)
Hshijiazhuang, Hebei, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2140)
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2139)
Wuhan, Hubei, China
Xiangya Hospital Central South University ( Site 2136)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2112)
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University ( Site 2121)
Nanchang, Jiangxi, China
Affiliated Cancer Hospital of Shandong First Medical University ( Site 2111)
Jinan, Shandong, China
Shanghai Pulmonary Hospital ( Site 2125)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 2137)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital of Fudan University ( Site 2119)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 2142)
Chengdu, Sichuan, China
The Third Peoples Hospital Of Chengdu ( Site 2141)
Chengdu, Sichuan, China
Sichuan Cancer hospital ( Site 2101)
Chengdu, Sichuan, China
The Affiliated Cancer Hospital of Xinjiang Medical ( Site 2110)
Urumuqi, Xinjiang, China
Yunnan Province Cancer Hospital ( Site 2131)
Kunming, Yunnan, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 2118)
Hangzhou, Zhejiang, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2103)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2117)
Hangzhou, Zhejiang, China
Ningbo No. 2 Hospital ( Site 2124)
Ningbo, Zhejiang, China
Promotora Médica Las Américas S.A. ( Site 0602)
Medellín, Antioquia, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0603)
Bogotá, Bogota D.C., Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0601)
Bogota, Cundinamarca, Colombia
Instituto Médico de Alta Tecnología S.A.S. ( Site 0605)
Montería, Departamento de Córdoba, Colombia
Oncologos Del Occidente ( Site 0606)
Pereira, Risaralda Department, Colombia
Hopital Nord ( Site 1004)
Marseille, Bouches-du-Rhone, France
Centre François Baclesse ( Site 1017)
Caen, Calvados, France
Centre de Cancérologie du Grand Montpellier ( Site 1016)
Montpellier, Languedoc-Roussillon, France
Centre Hospitalier Intercommunal ( Site 1019)
Créteil, Val-de-Marne, France
Evangelismos General Hospital of Athens ( Site 1204)
Athens, Attica, Greece
Errikos Dunant Hospital Center ( Site 1201)
Athens, Attica, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1206)
Athens, Attica, Greece
Athens Medical Center ( Site 1202)
Athens, Attica, Greece
Metaxa Cancer Hospital of Piraeus ( Site 1207)
Piraeus, Attica, Greece
G. Papanikolaou General Hospital ( Site 1203)
Thessaloniki, Central Macedonia, Greece
Queen Mary Hospital ( Site 3100)
Hong Kong, Hong Kong
Tuen Mun Hospital ( Site 3102)
Hong Kong, Hong Kong
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)
Milan, Lombardy, Italy
IEO Istituto Europeo di Oncologia ( Site 1405)
Milan, Lombardy, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
Roma, Italy
Hirosaki University Hospital ( Site 2200)
Hirosaki, Aomori, Japan
Hospital of the University of Occupational and Environmental Health, Japan ( Site 2214)
Kitakyushu, Fukuoka, Japan
Fukushima Medical University Hospital ( Site 2202)
Fukushima, Japan
Yamagata University Hospital ( Site 2201)
Yamagata, Japan
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1607)
Przemyśl, Podkarpackie Voivodeship, Poland
National Cancer Center ( Site 3603)
Goyang-si, Kyonggi-do, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 3602)
Suwon, Kyonggi-do, South Korea
Keimyung University Dongsan Hospital ( Site 3605)
Daegu, Taegu-Kwangyokshi, South Korea
Severance Hospital Yonsei University Health System ( Site 3601)
Seoul, South Korea
Asan Medical Center ( Site 3600)
Seoul, South Korea
Hospital Insular de Gran Canaria ( Site 1704)
Las Palmas de Gran Canaria, Canary Islands, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 1703)
Girona, Gerona, Spain
Hospital Puerta de Hierro ( Site 1705)
Majadahonda, Madrid, Spain
Hospital Universitari Vall d'Hebron ( Site 1700)
Barcelona, Spain
Hospital Clinico San Carlos ( Site 1706)
Madrid, Spain
Hospital Universitario la Paz ( Site 1710)
Madrid, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)
Madrid, Spain
H.R.U Malaga - Hospital General ( Site 1708)
Málaga, Spain
Hospital Universitario Virgen Macarena ( Site 1709)
Seville, Spain
Taipei Medical University Shuang Ho Hospital ( Site 3700)
New Taipei City, Taiwan
National Cheng Kung University Hospital ( Site 3706)
Tainan, Taiwan
Mackay Memorial Hospital ( Site 3701)
Taipei, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 3707)
Taipei, Taiwan
Tri-Service General Hospital ( Site 3708)
Taipei, Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1812)
Adana, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi ( Site 1827)
Adana, Turkey (Türkiye)
Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)
Ankara, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1810)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1811)
Ankara, Turkey (Türkiye)
Liv Hospital Ankara ( Site 1828)
Ankara, Turkey (Türkiye)
Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)
Istanbul, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)
Malatya, Turkey (Türkiye)